A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2
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Keep this study
Lead
Invivyd, Inc.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of Screening.
Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
Note: unless specified by Cohort, the criteria apply to both Cohorts
You may not be if
For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.
Clareo Health | A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2
